EU → North America Device Access

ORTOSERVIS s.r.o.

CZ-MF-000003866 · Czechia · Praha 8

ORTOSERVIS s.r.o. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: Chodítko STABILO, STABILO G3 BASIC, STABILO G3 GF, STABILO G3 M, Samostojná hrazda s madlem.

Devices declared under this manufacturer

Catalogue references include 20530, 20531, 20532, 20533, 20534, 20535.

European nomenclature codes declared: Y120606, V08068099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
Country of registrationCzechia

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN8
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. ORTOSERVIS s.r.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Czechia

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